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Late Acquired Malaposition and Different Polymers

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Medical University of Vienna

Status and phase

Completed
Phase 4

Conditions

Late Acquired Stent Malaposition

Treatments

Procedure: Biolimus-Eluting-Stent (BES)
Procedure: Everolimus-Eluting Stent (EES)
Procedure: Zotarolimus-Eluting-Stent (ZES)

Study type

Interventional

Funder types

Other

Identifiers

NCT02018991
MUW-0001

Details and patient eligibility

About

The polymers releasing the drug of first-generation drug-eluting stents (DES) may induce allergic reactions and inflammation, resulting in late-acquired stent malaposition (LASM) with uncoverage of struts, and risk of stent thrombosis. The incidence and predictors of LASM in DES with newer-generation polymers designed to improve biocompatibility are unknown.

Full description

please see brief summary

Enrollment

69 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients who underwent an elective treatment of a coronary lesion > 20mm with a DES

Exclusion criteria

  • chronic renal failure (serum creatinine ≥ 2.5mg/dl)
  • restenotic lesions

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

69 participants in 3 patient groups

Everolimus-Eluting-Stent (EES)
Active Comparator group
Description:
Patients treated with EES
Treatment:
Procedure: Everolimus-Eluting Stent (EES)
Zotarolimus-Eluting-Stent (ZES)
Active Comparator group
Description:
Patients treated with ZES
Treatment:
Procedure: Zotarolimus-Eluting-Stent (ZES)
Biolimus-Eluting-Stent (BES)
Active Comparator group
Description:
Patients treated with BES
Treatment:
Procedure: Biolimus-Eluting-Stent (BES)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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